device · product 1 of 2
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.
- Recall number
- Z-0225-2016
- Initiated
- September 28, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- GE Healthcare
- Quantity
- Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units
App-derived interpretation
Inaccurate distance measurements with magnified projection X-ray images.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
Reason for recall
Inaccurate distance measurements with magnified projection X-ray images.
Code information
2067131-001DVD UNIVERSAL VIEWER 5.0 - WEB CLIENT
Distribution pattern
Worldwide Distribution-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.